← Back to Search

Monoclonal Antibodies

Rozanolixizumab for Thrombocytopenic Purpura (myOpportunITy3 Trial)

Phase 3

Waitlist Available

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 53 or 55, compared to baseline

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study the effects of rozanolixizumab, a potential new drug, in people with a certain medical condition. The goal is to see if it is safe and effective.

Eligible Conditions

Thrombocytopenic Purpura

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 53 or 55, compared to baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 53 or 55, compared to baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 53 or 55, compared to baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With TEAEs Leading to Permanent Withdrawal of Rozanolixizumab (ie, Study Discontinuation)

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Secondary study objectives

Change From Baseline in Immune Thrombocytopenia-Patient Assessment Questionnaire (ITP-PAQ) to Week 53 or 55 Symptoms Domain Score

Percentage of Participants With Stable Clinically Meaningful Response Without Rescue Therapy at ≥70% of the Visits Over the Planned 52-week Treatment Period Starting at Week 4

Side effects data

From 2021 Phase 3 trial • 71 Patients • NCT04124965

30%

Headache

12%

Blood immunoglobulin G decreased

12%

Diarrhoea

10%

Urinary tract infection

Nausea

Pyrexia

Myasthenia gravis

Hypertension

Nasopharyngitis

Back pain

Abdominal pain

Hypogammaglobulinaemia

Retinal detachment

Muscular weakness

Cardiac failure congestive

Biopsy kidney abnormal

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Rozanolixizumab ~7 mg/kg

Rozanolixizumab ~10 mg/kg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Rozanolixizumab Treatment ArmExperimental Treatment1 Intervention

All study participants will receive fixed-unit doses of rozanolixizumab across body weight tiers at pre-specified time points during the Treatment Period. Doses will be adjusted based on platelet count values or medical needs.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rozanolixizumab

2023

Completed Phase 3

~620

Do I qualify?Apply below to find out